Institutional Review Board (IRB)

DOWNLOADABLE FORMS

Access essential IRB forms and standard operating procedures for ethical research oversight. Download the necessary documents to ensure compliance with regulatory and ethical guidelines.

STANDARD OPERATING PROCEDURE
Chapter 1 - IRB Structure and Composition
Introduction CHH IRB SOP v09
1.1 - Selection And Appointment Of Members
1.2 - Designation Of Officers
1.3 - Selection And Appointment Of Independent Consultants
1.4 - Training Of IRB Member And Staff
Chapter 2 - Types of Review
2.1 - Management of Initial Protocol Submissions
2.2 - Use of Assessment Forms
2.3 - Exempt from Review
2.4 - Expedited Review
2.5 - Full Board Review
2.6 - Resubmission Review
2.7 - Management of Appeal of Decision
Chapter 3 - Continuing Review
3.1 - Review of Amendments
3.2 - Review of Progress Report
3.3 - Review of Serious Adverse Events, SUSARS, UNE
3.4 - Review of Reportable Negative Events Reports
3.5 - Review of Protocol Violation Deviation
3.6 - Review Final Report
3.7 - Site Visits
3.8 - Managing Queries and Complaints
3.9 - Early Protocol Termination
Chapter 4 - Meetings
4.1 - Preparing for an IRB Meeting
4.2 - Conduct of Meetings
Chapter 5 - Documentation and Management of File Archiving
4.3 - Preparing the Meeting Minutes
4.4 - Communicating IRB Decisions
4.5 - Management of Incoming and Outgoing IRB Communications
4.6 - Managing Active Files
4.7 - Archiving of Inactive Files
4.8 - Managing Access to Confidential Files
4.9 - Management of Protocol Database
Chapter 6 - Writing and Revising SOP
5.1 - Writing and Revising SOP
Chapter 7 - Review of Medical Devices
6.1 - Review of Medical Devices
Chapter 8 - SJREB Review
8.1 - Response to Research Participants Request
8 - Glossary

DOWNLOABLE FORMS
APPLICATION FORM (for RESIDENTS STUDY) 1 of 4
APPLICATION FORM (for RESIDENTS STUDY) 2 of 4
APPLICATION FORM (for RESIDENTS STUDY) 3 of 4
APPLICATION FORM (for RESIDENTS STUDY) 4 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 1 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 2 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 3 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 4 of 4
ICF STANDARD TEMPLATE FORM
INVESTIGATORS BROCHURE STANDARD TEMPLATE FORM
PROTOCOL AMENDMENT STANDARD TEMPLATE FORM
PROTOCOL AMENDMENT SUBMISSION FORM
CONTINUING REVIEW APPLICATION FORM
END OF STUDY REPORT FORM
PROTOCOL DEVIATION-VIOLATION RECORD FORM
SERIOUS ADVERSE EVENT REPORT FORM
UNEXPECTED ADVERSE EVENT REPORT FORM